Drug product
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
D-0499-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 533,100 packets
- Official record key
drug-enforcement:D-0499-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: K9495, Exp. Date 02/2022; AK9614, Exp. Date 05/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations